(29 days)
No
The document explicitly states that ECG analysis capabilities have been removed from the device and are performed by separate software. There is no mention of AI or ML in the description of the device or its intended use.
No.
The device is described as a Holter recorder intended for diagnostic purposes (recording and evaluating electrical activity of the heart), not for providing therapy. It explicitly states that "ECG analysis is not a part of this device."
No
Explanation: The "Device Description" explicitly states, "As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review..." This indicates the device itself is a recorder and does not perform diagnostic (ECG analysis) functions.
No
The device description explicitly states that the modification is a change to the "digital Holter recorder hardware" and provides a table comparing the attributes of the new hardware model (#1005) to a previous model (DXP1000). This indicates the device includes physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is an electrocardiogram (ECG) recorder. It records the electrical activity of the heart from the body surface using electrodes. This is a non-invasive procedure that does not involve analyzing samples taken from the body.
- Intended Use: The intended use describes monitoring the electrical activity of the heart for various cardiac evaluations. This aligns with the function of an ECG, not an IVD.
- Device Description: The description focuses on the hardware and functionality of the ECG recorder, including data storage and transfer. It explicitly mentions the removal of ECG analysis capabilities from the device itself, with analysis being performed by separate software. This further reinforces that the device is a data acquisition tool, not a diagnostic test performed on a biological sample.
Therefore, the DigiTrakPlus Holter recorder, as described, is a medical device for recording physiological signals (ECG), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.
Ambulatory (Holter) ECG intended use:
The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.
-
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
-
- Clinical and epidemiological research studies.
-
- Evaluation of patients with pacemakers
-
- Reporting of time and frequency domain heart rate variability
-
- Reporting of QT Interval
Product codes (comma separated list FDA assigned to the subject device)
MWJ
Device Description
The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).
The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.
Storage capacity: Up to 48 hours
Memory type: Flash (non-volatile)
Memory portability: Non-removable
On-board ECG analysis: No
Liquid Crystal Display (LCD): Yes
Data transfer method: USB port
Pacemaker detection & reporting: Yes
Belt clip: Yes
Battery: One AA
Size: 11 x 7 x 2cm
Weight: 135g
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
NOV 2 4 1999
K9936/8
Section 2: 510(k) SUMMARY
- . Substantially Equivalent (SE) To:
Biosensor Model #1005 510(k) # K950944
Modification Background
The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).
The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.
| Attribute | DXP1000 | Model #1005 |
|---|---|---|
| Storage capacity | Up to 48 hours | 24 hours |
| Memory type | Flash (non-volatile) | Flash (non-volatile) |
| Memory portability | Non-removable | Non-removable |
| On-board ECG analysis | No | Yes |
| Liquid Crystal Display (LCD) | Yes | No |
| Data transfer method | USB port | Bi-directional parallel I/O |
| Pacemaker detection & reporting | Yes | Yes |
| Belt clip | Yes | No |
| Battery | One AA | Four AA |
| Size | 11 x 7 x 2cm | 15 x 6 x 2 cm |
| Weight | 135g | 140 g |
Comparison To The SE Device: .
NOTE: Together with this Special 510(k), another Special 510(k) has been filed on a similar device (DigiTrakPlus) utilizing alternative hardware which is slightly smaller in size. Both devices incorporate the same fundamental scientific technology, and indeed a substantially identical electro-mechanical design. For clarity, the submitter wishes to note to the reviewer that these two devices are essentially the same other than the size and weight characteristics noted.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a symbol of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1999
Mr. David Norberg Regulatory Affairs Representative Braemar, Inc. 11481 Rupp Drive 55337 Burnsville, Minnesota
Re: K993618 DXP1000 Holter Recorder Requlatory Class: II (two) Product Code: MWJ October 25, 1999 Dated: Received: October 26, 1999
Dear Mr. Norberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. David Norberg
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DXP1000 Holter Recorder
510(k) Number: K99 3618
Indications for Use:
(No change from predicate device)
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.
Ambulatory (Holter) ECG intended use:
The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.
-
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of a patient's response after resuming occupational activities (e.g.,
after M.I. or cardiac surgery.)
-
- Clinical and epidemiological research studies.
-
- Evaluation of patients with pacemakers
-
- Reporting of time and frequency domain heart rate variability
-
- Reporting of QT Interval
V. Darlene Rich
(Division Sign-Off Division of Cardiovascular, Respira and Neurological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)